Bristol Myers, Exelixis Reveal 4-Year Follow-Up Results From Cancer Treatment Study

Bristol Myers Squibb & Co BMY and Exelixis Inc EXEL revealed four-year follow-up results from a cancer study that compared one treatment with another from Pfizer Inc PFE.

What Happened: The Bristol Myers-Exelixis CheckMate -9ER trial evaluating Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) was held up against Pfizer’s Sutent (sunitinib) for previously untreated advanced or metastatic renal cell carcinoma (RCC). 

At a median follow-up of 55.6 months, all patients randomized to the Opdivo plus Cabometyx treatment arm (n=323) continued to experience benefits over those who received sunitinib (n=328) across efficacy endpoints:

• Progression-free survival (PFS) continued to favor Opdivo plus Cabometyx, with median PFS nearly doubled with the combination regimen at 16.4 months vs. 8.4 months with sunitinib.
• Treatment with Opdivo in combination with Cabometyx elicited durable survival benefit over sunitinib, with a median overall survival (OS) of 46.5 months compared to 36.0 months with sunitinib.
• The combination regimen showed durable response improvements, doubling the objective response rates (ORR) compared to sunitinib (55.7% vs. 27.7%, respectively).
• Patients who received Opdivo plus Cabometyx showed complete response (CR) benefit, with triple the number of patients achieving CR vs. sunitinib (13.6% vs. 4.6%).
• Opdivo plus Cabometyx was associated with a longer median Duration of response (DOR) of 22.0 months vs. 15.2 months in the sunitinib group.
• Benefits were observed in the favorable-risk and intermediate- and poor-risk groups.
• Among patients with intermediate-/poor-risk, the median OS was 43.9 months for those treated with Opdivo plus Cabometyx vs. 29.3 months with sunitinib. 
• In patients with favorable risk, median OS was similar across treatment arms at 52.9 months with the combination regimen and 58.9 months with sunitinib.
• PFS was improved with the combination regimen in patients with intermediate-/poor-risk with a median PFS of 15.4 months compared to 7.1 months with sunitinib and in those with favorable risk at 21.4 months vs. 12.8 months.
• In patients with intermediate-/poor risk, ORR was more than doubled at 52.6% with Opdivo and Cabometyx vs. 23.0% with sunitinib. In those with favorable risk, ORR was 66.2% vs. 44.4%, respectively.
• Among those with intermediate-/poor-risk profiles, the number of patients who achieved CR more than tripled (12.9% vs. 3.5%) with the combination regimen compared to sunitinib. 
• In those with favorable risk profiles, the number of patients who achieved CR was 16.2% vs. 8.3% with the combination regimen.
• Among the intermediate- and poor-risk groups, those treated with the combination regimen had a median DOR of 23.1 months vs. 13.8 months with sunitinib. 
• Among the favorable risk group, the median DOR was 18.7 months vs. 17.8 months, respectively.

What’s Next: These updated results will be featured at the American Society of Clinical Oncology 2024 Genitourinary Cancers Symposium.

Price Action: BMY shares closed at $49.58, and EXEL shares closed at $22.64 on Monday.

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